Combining exercise and medication to reduce bone loss during weight loss in older adults

The Bone, Exercise, Alendronate, and Caloric Restriction Trial

This study is testing if combining exercise and medication can help older adults lose weight without losing bone strength.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 900 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Drugs / interventions: denosumab
• Locations: 2 sites (Aurora, Colorado and 1 other locations)
• Trial ID: NCT05764733 on ClinicalTrials.gov

What this trial studies

This research aims to identify effective strategies to minimize bone loss in older adults undergoing weight loss. Participants will engage in a 12-month intervention that includes resistance training, bone-loading exercises, and bisphosphonate treatment, while all receiving a group-mediated dietary weight loss program. The study will assess changes in bone mineral density and quality through various imaging techniques over a period of up to two years. Participants will be randomized into one of four groups to evaluate the independent and combined effects of the interventions.

Who should consider this trial

Good fit: Ideal candidates are community-dwelling older adults with low bone density and a BMI of 25 or higher who are looking to lose weight.

Not a fit: Patients who are unable to walk independently or have severe musculoskeletal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help older adults maintain bone health while losing weight, reducing the risk of fractures and osteoporosis.

How similar studies have performed: Other studies have shown promising results with similar interventions aimed at preserving bone health during weight loss, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Community-dwelling
* BMI\>30 kg/m\^2 or BMI 25.0 to \<30 kg/m\^2 plus one risk factor
* Currently receiving routine (annual) dental care
* Pre-existing low bone mass (T-score ≤-1.1 to \>-2.5 at the hip, femoral neck, or lumbar spine (L1-L4))

Exclusion Criteria:

* Weight greater than 450 lbs (DXA limit)
* Resides with someone who is currently participating in BEACON
* Dependent on quad cane or walker; inability to walk independently
* History of mild cognitive impairment or dementia or evidence of cognitive impairment ((score \<20) on Montreal Cognitive Assessment (MoCA))
* Excessive alcohol use (\>21 drinks/week) in the past month; any non-cannabis illicit drug use
* Weight change ≥5% in past 3 months
* Regular participation (\>60 mins per day on \> 3 days/week) in structured strength training program for \>6 months
* Severe arthritis, fracture, chronic injury, or other musculoskeletal disorder that prevents safe exercise participation; joint replacement or other orthopedic surgery in past 6 months or planned in next 12 months; invasive dental procedure (i.e. extraction/implant) in past 6 month or planned in next 12 months
* Osteoporosis (any of the following): Self-reported and on prescription osteoporosis medication; self-reported prior spine, hip, wrist, or shoulder fracture after age 40 (except when caused by trauma or fall from height), including atypical femoral fractures (AFF); or ≥20% for major osteoporotic fracture at screening
* Uncontrolled hypertension (systolic \>180 OR diastolic \>110 mmHg) upon repeated assessments (up to 3 times)
* Uncontrolled type 2 diabetes (HbA1c \>8%); dialysis or abnormal kidney function (eGFR \<45 mL/min/1.73 m2); liver disease or abnormal liver function (ALT levels 2 times above normal); anemia (Hb\<LLN); calcium above or below normal limit; uncontrolled thyroid disease (hypo/hyper) or requiring recent (past 3 months) adjustments in thyroid hormone supplementation or thyroid-stimulating hormone \<LLN or \>10 mIU/ml; vitamin D deficiency (\<20 ng/mL).
* Stroke, heart attack, heart failure hospitalization, or revascularization procedure within the past 6 months; chronic respiratory disease requiring oxygen; PAD diagnosis within the last 12 months; uncontrolled angina; progressive neurological disease; malabsorption disorder; any disease suggesting a life-expectancy \<3 years; bilateral hip replacement; past or planned bariatric surgery; cancer requiring initial treatment within the last 12 months (except non-melanoma skin cancers); major vision or hearing loss; unstable gastric reflux; esophageal stricture, achalasia, or Barrett's esophagus
* Daily use of growth hormones, weight loss medications, oral steroids, or diabetes prescriptions (such as insulin, thiazolidinediones, or canagliflozin); known allergy to bisphosphonates; prior use of oral bisphosphonates for \>3 months within the past 3 years; zoledronic acid within the past 5 years; denosumab use within the past year; anabolic agents for \>3 months in the last year; current use of biotin or strontium; history of 3+ years of antiresorptive therapy
* Unable/unwilling to: provide own transportation to study visits, commit to study protocol (including random assignment), or adhere to data collection visits
* Current participation in another intervention research study; planned out-of-town trip greater than 1 month at a time during the first 6 months of the study; unwilling to provide informed consent, including consent to access personal electronic health records; judged unsuitable for the trial for any reason by research team

Where this trial is running

Aurora, Colorado and 1 other locations

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
• Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Kristen Beavers, PhD — Wake Forest University Health Sciences
• Study coordinator: Christa Todoroff Calderone, M.S.

Conditions Bone Loss; Older Adults; Weight Loss; Resistance Training; Osteoporosis; Osteopenia